Girgis Michael Magdy Fahmy, Farkasinszky Gergely, Fekete Klára, Fekete István, Vecsernyés Miklós, Bácskay Ildikó, Horváth László
Department of Pharmaceutical Surveillance and Economy, Faculty of Pharmacy, University of Debrecen, Debrecen, Hungary.
Division of Nuclear Medicine and Translational Imaging, Department of Medical Imaging, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.
Front Pharmacol. 2024 Jul 24;15:1411134. doi: 10.3389/fphar.2024.1411134. eCollection 2024.
Epilepsy is a widespread disease requiring long-term drug treatment. The aim of this study was to collect information on reported suspected adverse drug reactions (sADRs) of antiseizure medications (ASMs) and study their seriousness and outcomes in various system organ classifications (SOCs). We intended to compare old and new ASMs' ADRs. Using EudraVigilance (EV) database, we extracted line listings of reported sADRs with different ASMs over the period from January 2012 to December 2021. The list of ASMs was compiled according to the Anatomical therapeutic chemical classification system. The Medical Dictionary for Regulatory Activities version 24.0 was used for determining the SOCs of individual reported preferred terms (PTs) sADRs. In addition, we calculated the Reporting Odds Ratio (ROR), 95% confidence interval (95% CI), p-value (statistically significant if p< 0.05) and chi-square statistics. A total of 276,694 reports were contained in the exported line listings which included 1,051,142 individual sADRs reported as PTs such as seizure (3.49%), drug ineffective (2.46%), somnolence (1.32%), dizziness (1.29%) and represented four SOCs: nervous system disorders (19.26%), general disorders and administration site conditions (14.39%), psychiatric disorders (11.29%) and injury, poisoning and procedural complications (9.79). Among patients, the age group between 18 and 64 years had the highest percentage (52.40%), followed by those aged over 64 years (18.75%). Of all the reported PTs, 882,706 (83.98%) had reported seriousness. Old ASMs had a significant positive association with , , , and , while new ASMS with . There were 386 (0.04%) PTs related to Sudden Unexpected Death in Epilepsy (SUDEP). In our study, we examined 10 years' reported sADRs of ASMs in the EV international database. The majority of PTs were serious. Old ASMs were generally more commonly associated with undesired outcomes and seriousness. Considering their expected seriousness and outcomes, the safety profile of the different ASMs, can play a cardinal role in the selection of ASMs.
癫痫是一种需要长期药物治疗的广泛疾病。本研究的目的是收集有关抗癫痫药物（ASMs）报告的疑似药物不良反应（sADRs）的信息，并研究其在各种系统器官分类（SOCs）中的严重性和结局。我们旨在比较新旧ASMs的不良反应。使用欧洲药物警戒数据库（EudraVigilance，EV），我们提取了2012年1月至2021年12月期间不同ASMs报告的sADRs的线路清单。ASMs清单是根据解剖治疗化学分类系统编制的。使用《监管活动医学词典》第24.0版来确定各个报告的首选术语（PTs）sADRs的SOCs。此外，我们计算了报告比值比（ROR）、95%置信区间（95%CI）、p值（如果p<0.05则具有统计学意义）和卡方统计量。导出的线路清单中总共包含276,694份报告，其中包括1,051,142个作为PTs报告的个体sADRs，如癫痫发作（3.49%）、药物无效（2.46%）、嗜睡（1.32%）、头晕（1.29%），并代表四个SOCs：神经系统疾病（19.26%）、全身性疾病和给药部位状况（14.39%）、精神障碍（11.29%）以及损伤、中毒和操作并发症（9.79%）。在患者中，18至64岁年龄组的比例最高（52.40%），其次是64岁以上的患者（18.75%）。在所有报告的PTs中，882,706个（83.98%）报告了严重性。旧的ASMs与[此处原文缺失部分内容]、[此处原文缺失部分内容]、[此处原文缺失部分内容]和[此处原文缺失部分内容]有显著正相关，而新的ASMs与[此处原文缺失部分内容]有显著正相关。有386个（0.04%）PTs与癫痫性猝死（SUDEP）相关。在我们的研究中，我们检查了EV国际数据库中10年的ASMs报告的sADRs。大多数PTs是严重的。旧的ASMs通常更常与不良结局和严重性相关。考虑到它们预期的严重性和结局，不同ASMs的安全性概况在ASMs的选择中可以发挥关键作用。
